Legal Protection of the Right of Informed Consent of the Subjects of Human Clinical Trials in China

MENG Xianghan

Abstract:The“informed consent principle”in human clinical trials is the product of the extension of the concept of human rights in the field of human trials and a reflection of the progress of human civilization in biomedical research∙ In recent years,the legal protection of the right to informed consent for research subjects has been gradually improved in China∙ The right to informed consent for research subjects has been improved from an ethical norm to a legal norm∙ The legal status of legal norms has also been gradually improved∙ Based on the public law regulations,private law relief has been added to the legal relief system for the infringement of the right to informed consent for research subjects∙ As a result,the protection of rights has been enhanced∙ The domestic informed consent protection system is partially in line with international norms∙ The protection of the right to informed consent depends on the perfection of the legal system and the social consensus to respect human rights and the right to self-determination∙

Keywords:subjects ◆ right to informed consent ◆ obligation to inform ◆ human clinical trials

The research and development of COVID-19 vaccines has once again brought the“subjects”of biomedical research from behind the scenes.This special group of people has been around for a long time and has made great contributions to biomedical development.As stated in theDeclaration of Helsinki:“Medical progress is based on research that ultimately must include studies involving human subjects.”Behind clinical trials are a large number of research subjects.While honoring the active participation of the research subjects in clinical trials,they should also be given due legal protection.Only in this way,can medical research go further.

As a widely accepted basic principle in modern society,informed consent is the core protection for the subjects of human clinical trials.People often know much about the right to informed consent in the conventional medical field,but know little about the right to informed consent in human clinical trials.Also,the legal protection of the right to informed consent in human clinical trials lags behind that in the conventional medical field.Starting from reviewing the establishment of the core position of the right of research subjects to informed consent,this paper summarizes the develop-ment of legal protection of the right of research subjects to informed consent in China,analyzes the content of the right to informed consent based on the specific provisions of laws and regulations,and predicts the future development of the right of research subjects to informed consent.

I.Historical Review of the Establishment of the Core Position of the Right of Subjects to Informed Consent

“The right to informed consent is not only an important content of the personal dignity with free will as the core and the right to self-determination of natural persons but also a core mechanism to protect the rights to life,body,and health of subjects.”1.Man Hongjie,“Legislative Proposals on the Right of Subjects to Informed Consent”,Journal of Sichuan University (philosophy and Social Science Edition) 3 (2018).The right to informed consent in the modern sense originated from the Nuremberg Trials after World War II.During the Nazi period in the 20th century,Nazi Germany conducted a series of extremely brutal and appalling illegal human trials in concentration camps.For example,they immersed living people in ice water until they died to determine the human body’s ability to withstand cold temperatures;they deliberately cut off human limbs to test the hemostatic efficacy of new drugs;they simply released poison gas or killed concentration camp inhabitants with lethal injections to figure out the best way to exterminate them.The Nazis were not the only ones who carried out horrific human experiments in the name of scientific research.The Japanese military committed similar atrocities on Chinese prisoners of war and civilians in northeast China from 1931 to 1945.To develop bacteriological weapons,the Japanese Unit 731 carried out equally inhumane plague and frostbite experiments in rural areas near Harbin,2.The film Man Behind the Sun,released in 1988,recorded the real history of the Japanese Unit 731’s bacterial experimentation in China.Some said that the atrocities committed by the Unit 731 were even worse than those committed by Nazi Germany.However,Nazi Germany went through the Nuremberg Trials,while Japan’s experimentation atrocities were never prosecuted because the United States sought to obtain the data.For this reason,there has been a lack of deep reflection on Japan's medical atrocities in East Asia for more than half a century.Yoshimura Hisato,who led the frostbite experiment,even published a book using data from human trials and was awarded the Order of the Rising Sun 3rd Class,Japan’s highest honor.which were detailed in Sheldon H.Harris’s bookFactories of Death:Japanese Biological Warfare,1932-1945,and the American Cover-up.3.Sheldon H.Harris,Factories of Death:Japanese Biological Warfare,1932-1945,and the American Cover-up,translated by Wang Xuan,et,al.,(Shanghai:Shanghai People’s Publishing House,2000).

The above illegal human experiments were conducted without the informed consent of the research subjects,and many of them caused untold suffering and even death.Although some of these experiments yielded valid scientific results,most of them lacked proper experimental procedures or were simply carried out to satisfy the psychological needs of abuse and obscenity.The fact that victims were subjected to inhuman and barbaric experiments made people pay close attention to the use of research subjects in human trials without their consent.Thus,as a reflection on Nazi Germany’s inhumane human experimentation,the International Military Tribunal at Nuremberg declared ten basic principles on human experimentation in 1947,known astheNuremberg Code.Article 1 of the Code confirms that“The voluntary consent of the human subject is essential,”which highlights the core status of voluntary consent of research subjects in human trials.As a result,theNuremberg Codehas become the source of international and national legal and ethical norms for human trials.

TheDeclaration of Helsinkiis an international norm that was enacted based on the issues of human experimentation during and after World War II.In June 1964,the 18thWorld Medical Association discussed and adopted theEthical principle for Medical Research Involving Human Subjectsin Helsinki,Finland,commonly known as theDeclaration of Helsinki.The concept of“informed consent”was first explicitly proposed in this declaration.4.Liu Yueshu,“Adaptation of Informed Consent Principle to the Chinese Context:A Transformation from the Perspective of Bioethics”,Studies in Ethics 1 (2013).In the following decades,informed consent has become the core principle of biomedical research in many countries including China.

It is generally believed that the principle of informed consent was introduced into China in the middle and late 1980s with the influx of foreign medical humanistic ideas.At first,it only appeared in translated works,textbooks,and academic papers,5.Ren Jinghui,“On the Development Origin and Common Problems of the Right to Informed Consent”,Chinese Medical Record 9 (2014).but it was gradually institutionalized and legalized later.This is because human clinical trials are indispensable for advancing medical science.All countries in the world attach great importance to the research and development of new drugs,new medical technologies,and medical devices,and actively seek breakthroughs.Given the high risks of human clinical trials,“it is natural for the state to exercise strict administrative control over their licensing and implementation based on the responsibility of public service management.”6.Wang Yue,“Legal Analysis and Advice on Clinical Trial of Medicine from ‘Korean Ginseng Bolus Event’”,China pharmacy 10 (2005).As the core of legal protection of research subjects,it is of high necessity for the principle of informed consent to be institutionalized and legalized.Under the guidance of international ethical norms and laws,especially the basic spirit of theDeclaration of Helsinki,the right of research subjects to informed consent in China has been upgraded from an ethical norm to formal legal norm,providing more effective protection for the research subjects of human clinical trials.

If there is a need to define the right of research subjects to informed consent to clarify its nature,scope,and content,it can be expressed concisely as:the right of informed consent7.In mainland of China,“informed consent”is widely translated as“zhiqing tongyi”in Chinese,while in Taiwan Province of China,it is often translated as“gaozhi hou tongyi”.of the research subject refers to the right of the research subject to be adequately informed of the information related to the study,including the nature,purposes,methods,procedures,possible risks,anticipated benefits,etc.of human trials,and to voluntarily decide whether to participate in the trials or not based on a full understanding of the information and without coercion,threat or undue influence.Protecting the right to informed consent is mainly to ensure the individual autonomy of the research subject,encourage rational decision-making,avoid fraud and coercion from the experimenter,promote the self-supervision of the experimenter,and reduce the risk of the experimenter bearing civil and criminal liabilities.8.Robert J.Levine,“Consent Issues in Human Research”,in Ethical and Regulation Aspects of Clinical Research,Ezekiel J Emanuel et al.ed.,2003),197-198.

II.Development of Legal Protection of the Right of Subjects to Informed Consent in China

Like the development of the protection of many rights,the legal protection of the right to informed consent of research subjects in China has also experienced a process from nothing to something,and from non-standardized to standardized.In general,the main trend of this process is reflected in the following five aspects:first,the rights protection of research subjects has been upgraded from ethical norms to legal norms;second,the legal status of legal norms has gradually risen;third,the legal relief system for the infringement of the right to informed consent of the research subject has been constantly improved,and private law relief has been added based on the public law regulations;fourth,the protection of rights has been more comprehensive;fifth,the domestic protection system for the right to informed consent is partially in line with international norms.

A.From ethical norms to legal norms

Some scholars have summarized the norms of human trials in the world into three models.The first is legislative norms,which include special legislation and Civil Code provisions.For example,France enacted theLoi Huriet-Serusclatas early as 1988.9.The Loi Huriet-Serusclat,known as loi Huriet.The law has been amended several times and became part of the French Code of Public Health in 2000.Quebec,Canada,added provisions on the right to personal integrity of research subjects in theQuebec Civil Codewhen revising it in 2013.The second is administrative regulations,represented by the Common Rule of the United States.10.In 1991,the U.S.Federal Department of Education,Health and Welfare codified the regulations on human experimentation applied by the Federal administrative departments into the Common Federal Policy,which became a part of the Federal Administrative Code,also known as the Common Rule.Major revisions were made in 2005,2017 and 2018.See Federal Policy for Human Subject (“Common Rule”),accessed January 6,2022,https:// wvrw.hs.gov/ohrp/.The third is ethical norms,namely,to regulate human trials with ethical norms.11.Man Hongjie,Study on Legal problems of Human Experiments (Beijing:China Legal Publishing House,2013),54;Man Hongjie,“Legislative Proposals on the Right of Subjects to Informed Consent”,Journal of Sichuan University (philosophy and Social Science Edition) 3 (2018).

According to the classification,the norms of the protection of the rights of research subjects in China have realized a transition from ethical norms to administrative regulations.“In the early days,respecting and protecting the voluntary consent of biomedical research subjects was only an ethical principle in the early stage.However,where respecting and protecting the autonomy,privacy,life,and health of individuals,including subjects,is already a legal requirement,it is natural to carry out corresponding legislation to internalize the ethical principle into law through mechanisms such as‘informed consent’.”12.Zhao Peng,“Legalization of Ethical Regulation in Biomedical Research”,China Legal Science 6 (2021).Article 33 of theRegulations on the Administration of Medical Institutionsissued in 1994 stipulates:“Where any surgery,special examination or special treatment is to be performed,the signed consent of the patient and the signed consent of the patient’s family members or relatives must be obtained.When a patient’s opinion is unobtainable,the patient’s family members or relatives shall give consent and sign the consent form.If a patient’s opinion is unobtainable and the patient’s family members or relatives are not present,or in other special circumstances,the attending physician shall propose a therapeutic schedule and implement it after obtaining the approval of the responsible person of the medical institution or other authorized responsible persons.”Article 88 of the Implementation Rules for theRegulations on the Administration of Medical Institutionsissued in the same year states that“Special examination and special treatment”includes experimental clinical examination and treatment.This means that the right to informed consent has been upgraded from an ethical norm to administrative regulation.Over the next 20 years,there was successive legislation on the right of research subjects to informed consent.A series of laws and regulations such astheLaw on practicing Doctors,theStandards for Quality Management of Drug Clinical Trials,and theMental Health Lawhave been promulgated on the right to informed consent of research subjects in the medical field,subjects for clinical trials of drugs,and patients with mental disorders.The change of model has greatly improved its binding force and coercive force and given more effective protection to the right to informed consent of research subjects.

As the“declaration of people’s rights in the new era”,theCivil Code of the people’s Republic of China(hereinafter referred to as the Civil Code) actively responds to the needs of the times and stipulates in Article 1008 that:“Where a clinical trial is needed for developing new drugs and medical devices or developing new prevention and treatment methods,upon approval of the relevant competent authorities and the examination and approval of the ethics committee,the participants or the guardians thereof shall be informed of the details including the purposes,methods,and the possible risks of the trial,and their written consent must be obtained.When conducting a clinical trial,no fees may be collected from the participants of the trial.”The first law defined as a code since the founding of the People’s Republic of China,theCivil Codeis of milestone significance.And the inclusion of the right of research subjects to informed consent in theCivil Codeis of great theoretical and practical significance for improving the legal protection system of research subjects’ rights and interests and promoting the good law and good governance of biomedical research in China.However,it should also be noted that theCivil Codeonly stipulates the right to informed consent of research subjects in a single article in the“Part on Personality Rights”,which is relatively general and simple,and there is no special“law on human trials”in China.Therefore,the dominant legal norms for the protection of this right are still administrative regulations,and the current norms for the right of research subjects to informed consent still adopt the mode of administrative regulations in China.

B.Gradual improvement in the status of legal norms

In the past,most of the legal norms for the protection of human clinical trial subjects in China were administrative laws and regulations,with a relatively low legal status.13.Only two laws,the Law of the People’s Republic of China on Practicing Doctors and the Mental Health Law of the People’s Republic of China,provide a few provisions on experimental clinical treatment.Administrative laws include theRegulations on the Administration of Medical Institutionsenacted by the State Council in 1994 and revised in 2016;administrative regulations includetheStandards for Quality Management of Drug Clinical Trialsenacted by the China Food and Drug Administration in 2003 and revised in 2020,theGuidelines for Ethical Review of Drug Clinical Trialsissued in 2010,theGuidelines for the Management of phase I Clinical Trials of Drugs (Trial)issued in 2011,theStandards for practitioners in Medical Institutionsjointly issued by the former Ministry of Health,China Food and Drug Administration and National Administration of Traditional Chinese Medicine in 2012,theStandards for Quality Management of Medical Device Clinical Trialsenactedand promulgated by the China Food and Drug Administration and the National Health and Family Planning Commission in 2016,14.In 2004,the former State Food and Drug Administration issued the Regulations on Clinical Trials of Medical Devices,which played a positive role in regulating clinical trials of medical devices.But with the deepening of the cognition for clinical trials of medical devices,its deficiencies gradually became apparent,such as the principled and rough provisions,and incomprehensive and vague clauses.Moreover,with the rapid application of biotechnology,electronic information technology and new material science,it was difficult for the regulations to meet the current situation of clinical trial management of medical devices.In this context,the China Food and Drug Administration and the National Health and Family Planning Commission formulated the Standards in 2016 based on China’s actual situation.and theMeasures for the Ethical Review of Biomedical Research Involving Humansenacted by the National Health and Family Planning Commission in 2016.15.The National Health Commission summarized the effective institutional arrangements in the Measures for the Ethical Review of Biomedical Research Involving Humans,and worked with related departments to draft the Measures for the Ethical Review of Life Science and Medical Research Involving Humans (Draft for Comments) in light of the new situation and requirements,which was released to the public for comments in March 2021.

With the rapid development of biomedical research and the acceleration of legalization in China,the low legal status has been greatly improved.In the past two years,three newly enacted laws (codes) in China have incorporated the protection of the right to informed consent of research subjects,namely,theCivil Codeadopted in 2020,16.Article 1008 of the Civil Code of the People’s Republic of China states:“Where a clinical trial is needed for developing new drugs and medical devices or developing new prevention and treatment methods,upon approval of the relevant competent authorities and the examination and approval of the ethics committee,the participants or the guardians thereof shall be informed of the details including the purposes,methods,and the possible risks of the trial,and their written consent must be obtained.When conducting a clinical trial,no fees may be collected from the participants of the trial.”theLaw on the promotion of Basic Medical and Health Care,17.Article 32 (3) of the Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care states that“Clinical experiments and other medical research of drugs and medical devices shall comply with the medical ethics and specifications,pass an ethical review according to the law,and obtain informed consent.”and theVaccine Administration Lawadopted in 2019.18.Article 18 of the Vaccine Administration Law of the People’s Republic of China states that“Written informed consent shall be obtained from subjects for vaccine clinical trials;where the subject is a person without capacity for civil conduct,the written informed consent shall be obtained from his guardian;where the subject is a person with limited capacity for civil conduct,the written informed consent shall be obtained from the subject and his guardian.”In addition,theDrug Administration Law,which was enacted in 1984 and first amended in 2001,focused more on human rights protection and added specific provisions on the right to informed consent of research subjects in the second amendment in 2019.The adoption and amendment of theCivil Codeand the above laws have broadened the boundaries and fields of legal protection for research subjects and improved the status of legal norms for research subjects.In particular,the incorporation of the rights and interests protection of human clinical trial subjects into theCivil Coderepresents the first positive response of China to the rights and interests protection of clinical trial subjects from the perspective of civil legislation,and the first explicit stipulation in China’s civil law system on the right to informed consent of subjects,which has solved the problem of low legislative level and weak legal protection for subjects to a certain extent.

However,because of the presence of lots of laws and regulations concerning the right to informed consent of research subjects and the difference in legislative subjects and time,there is a lack of unified standards on the research subject and content of the right to informed consent.Such legislative inconsistencies will easily lead to difficulties in the application of the law.This paper will analyze different legislative provisions from the perspective of jurisprudence to resolve the confusion about the right to informed consent.

C.Constant improvement of the legal relief system

The legal protection of the right to informed consent of research subjects has experienced a process from public law regulation to public law and private law cooperation.“It is not only possible but also necessary to regulate biotechnology through private laws.The characteristics of private laws,such as high inclusiveness and value orientation,give them unique advantages and make them depend on and cooperate with public law regulation.”19.Tian Ye,“The Private Law Approach to Biotechnology Challenges”,Academic Monthly 3 (2020).

Before the promulgation of theCivil Code,the legal protection of the right of subjects to informed consent was mostly stipulated in administrative laws and other“public laws”,such as theLaw on the promotion of Basic Medical and Health Care,theVaccine Administration Law,theDrug Administration Law,theLaw on practicing Doctors,theStandards for Quality Management of Drug Clinical Trials.According to the above laws and regulations,illegal clinical trials can only lead to administrative or criminal liabilities,but subjects can hardly get effective compensation for their material and spiritual damage.There is no effective relief for the private rights of subjects.For example,Article 37 of theLaw on practicing Doctorsstipulates that any doctor violating the right to informed consent shall be warned or suspended from medical practice.If the case is serious,his practicing certificate shall be revoked.Where a crime is constituted,he shall be investigated and prosecuted for criminal responsibility according to the law.Public laws aim to limit arbitrary power,protect human rights,and focus on the maintenance of social order and social fairness,with their advantages lying in the strong control of clinical trials by the state's coercive force.Private laws reflect the autonomy and equality of the rights of the research subjects,highlight freedom and efficiency,and focus on the protection and relief of rights.20.Sun Guohua and Yang Sibin,“The Division of Public Law and Private Law and the Internal Structure of Law”,Law and Social Development 4 (2004).

The incorporation of the right of research subjects to informed consent into the Part on Personality Rights of theCivil Coderealizes the empowerment of private laws.The explicit provisions on this right in theCivil Codemake up for the deficiency of public law relief,demarcate the boundary of“private laws”for clinical trials,and provide a legitimate basis for subjects to seek civil relief and identify violations.When the relevant parties of clinical trials fail to fulfill their obligation of full,comprehensive,and active disclosure,thus causing damage to the right to informed consent of subjects,the subjects can directly seek civil law protection,hence improving the legal relief system for the rights of research subjects.

D.More comprehensive protection of rights

Research subjects are not limited to sick patients,but also include non-therapeutic healthy subjects.This is determined by the nature and stage of human clinical trials.In the first phase of a trial,a preliminary test should be conducted to determine the safe dose of the drug that can be used,which is mainly for healthy people.21.For detailed description of the stages of human trials,see Huang Dingquan,Medical Law and Bioethics (Beijing:Law Press·China,2007),344.Previous laws only provided for the rights protection of patients in therapeutic clinical trials,and contained the terms“physicians”,“patients”,and“family members,”but they ignored healthy people as research subjects.With the deepening of biomedical research and the promotion of infringement cases about the right to informed consent in practice,the protection of clinical trial subjects in China has been more comprehensive,and legislative terms have been more standardized.This trend can be seen in theLaw on Doctorsenacted in 2021.

On March 1,2022,theLaw on Doctorscame into force,and theLaw on practicing Doctorswas abolished at the same time.The differences in the protection of subjects’ rights between the new and old laws are particularly evident through the comparison of their articles.22.Article 26 (2) of the Law on Practicing Doctors stipulates that“Doctors shall get the approval from the hospital and the consent of the patient or family members before conducting clinical treatment on an experimental basis.”Article 37 stipulates the legal liability for violation of the right to informed consent.Specifically,any doctor who conducts experimental clinic treatment on a patient without the consent of the patient or his family members shall be warned or suspended from medical practice.If the case is serious,the doctor’s practicing certificate shall be revoked.Where a crime is constituted,the doctor shall be investigated and prosecuted for criminal responsibility according to law.Article 26 of the Law on Doctors stipulates that“Doctors who carry out clinical trials of drugs and medical devices and other medical clinical studies shall comply with relevant national regulations,abide by medical ethics and norms,pass ethical review in accordance with law and obtain written informed consent.”Article 55 stipulates the legal liability for violation of the right to informed consent:“Doctors violating this law and having one of the following behaviors during the course of medical practice shall be warned by the health administration departments of the people’s governments at or above the county level;in serious cases,they shall be suspended from medical practice for a period between six months and one year,until their practicing certificates are revoked:(1) Failing to perform the obligation to inform or obtain informed consent as prescribed in providing medical and health services or carrying out medical clinical research…”It can be seen from the comparison that:

First,the words“patients or their family members”was deleted from theLaw on Doctors,and the law extends the protection to non-therapeutic healthy subjects.Second,theLaw on Doctorschanges the provision“get the approval from the hospital and the consent of the patient or family members”to“comply with relevant national regulations,abide by medical ethics and norms,pass ethical review in accordance with law and obtain written informed consent,”changes the examination and approval subject of clinical trials from the hospital to the subject meeting the relevant national regulations,which is more standardized and adds the ethical review link,which is more comprehensive.Third,theLaw on Doctorsdefines the form of informed consent as“written informed consent,”which avoids the disadvantage of oral consent in previous practice.

The emergence of the above trend is closely related to the practice and legislation of biomedical research in China.However,not all laws on the right of subjects to informed consent protect the subjects of rights so comprehensively.For example,theRegulations on the Administration of Medical Institutionsand theRegulations for practitioners of Medical Institutionsformulated in the early stage stipulate that the subjects of informed consent are“patients,”“patients”family members or relatives”and“patients or their family members,”rather than“subjects or their guardians,”which indicates the legislative inconsistency mentioned above.

E.Domestic protection system partially in line with international norms

Because of the high risks and uncertainty of human clinical trials,it is particularly important to protect the rights of research subjects.With the cross-border development of biomedical research,it is necessary to standardize human clinical trials in different countries.In this context,various international organizations have developed international norms of varying effectiveness23.Such as the Declaration of Helsinki adopted by the World Medical Association in 1964;the International Covenant on Civil and Political Rights adopted by the United Nations General Assembly in 1966;the International Ethical Guidelines for Biomedical Research Involving Human Subjects jointly issued by the Council for International Organizations of Medical Sciences and the World Health Organization in 1982;the Guidelines for Good Clinical Practice (ICH-GCP) formulated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use in 1996;the Universal Declaration on Bioethics and Human Rights issued by the United Nations Educational,Scientific and Cultural Organization in 2005,etc.to provide universal norms for the protection of subjects in human clinical trials.TheDeclaration of Helsinkiand theGuidelines for Good Clinical practice(ICH-GCP) formulated by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) is the one with the biggest impact on China.

TheDeclaration of Helsinkisupplements the relatively simple and abstract ethical principles of theNuremberg Codewith more comprehensive provisions and clarifies the right to informed consent in detail in 9 articles (out of 35 articles),including the content and forms of informed consent,informed consent of minors and informed consent under special circumstances.Since its enaction,the Declaration of Helsinki has been revised seven times,24.The Declaration of Helsinki was revised in 1975,1983,1989,1996,2000,2008 and 2013.and many specific items have been revised and added,and had a profound impact on human trials in the entire Western society and other regions.TheDeclaration of Helsinkihas become the most influential one among the current international norms on human trials.

In 1989,the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) was established in Paris by the drug regulatory departments and pharmaceutical industry authorities in Europe,Japan,and the United States.ICH formulated theGuidelines for Good Clin-ical practice(ICH-GCP) through negotiation in Virginia,the United States in 1996,setting out ethical rules for human trials of drugs.ICH-GCP makes detailed provisions on the composition and review mechanism of the ethics committee as well as the approval and signing of the informed consent of subjects.Because of the dominant position of Europe,Japan,and the United States in the world pharmaceutical field and the global presence of pharmaceutical research and development,ICH-GCP has had a considerable influence on the human trials of drugs in countries around the world.

In recent years,some administrative regulations in China have fully incorporated the contents of some international norms to protect the right to informed consent of subjects,further realizing the consistency between basic legislation and professional norms.TheStandards for Quality Management of Drug Clinical Trials,formulated in 2003 and revised in 2020,is a model for the domestic legal protection of the right to informed consent to be in line with international standards.Article 3 of theStandards for Quality Management of Drug Clinical Trialsstipulates that the protection of subjects’ rights in China shall be consistent with international norms and ethical principles:“Drug clinical trials shall comply with the principles and related ethical requirements in theDeclaration of Helsinkiof the World Medical Association,and the rights and safety of subjects shall take precedence over the scientific and social benefits.Ethical review and informed consent are important measures to protect the rights and interests of subjects.”

Meanwhile,the relevant institutions of the Chinese government have actively participated in international conferences and organizations for the protection of the rights of subjects and introduced new ideas and practices in this field to China.The first ICH Meeting was held in Montreal,Canada from May 31 to June 1,2017.At the meeting,the former State Food and Drug Administration of China was approved to be a full member of ICH.In June 2018,the National Medical Products Administration of China was elected as a member of the ICH Management Committee.Since then,China has actively sought conformance to relevant provisions of the ICH-GCP and started to revise theStandards for Quality Management of Drug Clinical Trials.The 2003 version of theStandards for Quality Management of Drug Clinical Trialsonly explains the content of informed consent in the form of concept,but after the revision in 2020,it has realized a consistency with the basic requirements of ICH technical guidelines,with the provisions on the content of informed consent directly using the translation of the content in ICE-GCPE6 (R2).25.Wang Meixia and Li Yiting,“Changes in the Policy of Informed Consent for Drug Clinical Trials in China:A Comparison between GCP 2003 and GCP 2020”,Medicine &philosophy 15 (2020).Compared with the 2003 version,it is more concrete,comprehensive,and operable.This indicates that the legal protection of the right to informed consent of drug clinical trial subjects in China has been in line with international norms and the efforts of protection have been greatly strengthened.

In addition to the research and development of new drugs,the clinical trials of new medical devices and new therapies have not yet met international norms,because of the lack of preparations in the biomedical research field and the consideration of whether international norms and standards fit in with the actual situation in China.

III.Institutional Mechanism for Legislation of the Right of Subjects to Informed Consent in China

It can be seen from the review of the development process that in recent years,China has continuously improved the legal protection of the right to informed consent of research subjects and made great progress in legislation.However,there are still inconsistencies in legislation due to the difference in legislative subjects and legislative time.The legal protection of research subjects should be realized through the implementation of the legal norms mentioned above.The problem of inconsistency in legislation will inevitably lead to difficulties in the application of laws in practice.Therefore,after reviewing the establishment of the core position of the right of research subjects to informed consent and summarizing the development trend of legal protection in China,we will make a specific analysis of the subject of rights and obligations and the content of the right to informed consent of research subjects based on the current laws and regulations in China,to further explore the legal connotation and institutional mechanism of the right.

A.Inconsistency in legislation on the subject of rights and obligations

1.Who will inform?——multiple subjects of the obligation to inform

The extent to which the clinical investigators fulfill the obligation to inform determines to what extent the research subject is informed.The obligation to inform requires that the clinical investigators shall provide the research subject with comprehensive and sufficient information about the experiment before and during the experiment,so that the research subject can decide whether to participate or continue to participate in the experiment or not,thus ensuring the research subject’s right to be informed.In the current laws,administrative regulations,and rules that stipulate the right to informed consent of research subjects,there are some provisions on the subject of the obligation to inform,but there is no unified standard.According to the specific provisions of various laws,regulations,and rules,the subject of the obligation to inform can be roughly divided into the following groups.

The first group is the implicit subjects of the obligation to inform.The Part on Personality Rights of theCivil Code,theLaw on the promotion of Basic Medical and Health Care,theVaccine Administration Law,theDrug Administration Law,etc.,all avoid specifying the subject of obligation to inform,and positively make provisions on the right of subjects to informed consent from the perspective of subjects’ rights.Considering the high specialization of human trials,this legislative treatment is a wise choice.The second group is doctors.Article 26 (2) of theLaw on practicing Doctorsstipulates that“Doctors shall get the approval from the hospital and the consent of the patient or family members before conducting clinical treatment on an experimental basis.”26.Article 26 of the Law on Doctors,which took effect on March 1,2021,also stipulates that doctors are the subject of the obligation to inform.Some scholars have argued that theLaw on practicing Doctorsonly makes principled provisions on the right to consent of research subjects and does not explicitly state the obligation of doctors to inform in experimental clinical treatment,thus there exists the defect that“only the right of consent is stipulated,but not the obligation to inform.”27.For detailed analysis,see Xu Xirong,“On the Right to Informed Consent in Human Trials——From the Perspective of ‘Golden Rice’ Event”,Hebei Law Science 11 (2013).The third group is the medical staff.Article 27 of theStandards for practitioners in Medical Institutionsstipulates that medical staff are the subject of the obligation to inform.The fourth group is medical institutions.TheMental Health Lawand Article 33 of theRegulations on the Administration of Medical Institutionstake medical institutions as the subject of the obligation to inform.The fifth group is the researchers,the clinical investigators and their sponsors.Article 23 of theStandards for Quality Management of Drug Clinical Trials,Article 21 of theStandards for Quality Management of Medical Device Clinical Trials,and Article 33 of theMeasures for the Ethical Review of Biomedical Research Involving Humansall regard“researchers”as the subject of the obligation to inform.

According to the organization of articles,in the current laws of China,there is no unified provision on the subject of the obligation to inform in human trials.Some laws do not specify the subject,some regard“doctors”,“medical staff”,“practitioners of medical institutions,”“researchers”and other natural persons as the subject,and some others take legal persons or other organizations such as“medical institutions”as the subject.The wide and chaotic scope of the subject of the obligation to inform is not conducive to the effective performance of the obligation,nor to the identification of the subject of legal relations and the investigation of responsibility.Therefore,it is necessary to clarify the subject of the obligation.

Generally,the difference in the subjects of the obligation to inform specified by laws,regulations,and rules results from the different objects under their regulation.For example,theLaw on practicing Doctorsis formulated for doctors,while theRegulations on the Administration of Medical Institutionsis issued for medical institutions.Moreover,the above laws and regulations are administrative laws or public laws,rather than private laws that directly regulate the relationship of rights and obligations between individuals.Therefore,who shall fulfill the obligation to inform in the civil legal relationship of human trials shall be judged according to the theory of civil law.

In human clinical trials,the clinical investigators and the research subjects constitute a civil legal relationship with specific civil rights and civil obligations as the content.Therefore,the investigators’ obligation to inform is not only an ethical obligation but also a legal obligation,which can produce certain legal effects.This obligation is based on the legal relationship of human trials,which is performed by the opposite party in the civil legal relationship.“Doctors”or“medical staff”execute various procedures of human trials and communicate with the research subjects directly,but,as employees of medical institutions,their performance should be deemed as duty behavior and they are not the subject of the civil legal relationship of human trials.Medical institutions are the opposite party in the legal relationship and shall fulfill the obligation to inform according to the law.It can also be seen from the judicial practice in China that in disputes over human trials,the defendant is not a doctor,but usually,the hospital that undertakes the human trial project,namely the medical institution.

2.Who will be informed?——Family members or guardian

Based on the analysis of the legal provisions for human clinical trials,the laws,regulations,and rules concerning the right of subjects to informed consent in China can be divided into two categories,as to the subject of informed consent,that is,the object of the obligation to inform.The first category includes theCivil Code,theVaccine Administration Law,theDrug Administration Law,theMental Health Law,theStandards for Quality Management of Drug Clinical Trials,and theStandards for Quality Management of Medical Device Clinical Trialswhich stipulate that the subject of informed consent is“the subject or the subject’s guardian,”“the subject and his guardian,”“the patient or his guardian,”“the subject’s guardian or legal agent.”The second category includes theRegulations on the Administration of Medical Institutionsand theStandards for practitioners in Medical Institutionswhich stipulate that the subject of informed consent is“the patient,”“the patient’s family members or relatives,”“the patient or his family members.”

“Family members”is not strictly a legal term,with no clear boundaries.TheRegulations on the Administration of Medical Institutionsstates that“Where any surgery,special examination,or special treatment is to be performed,the signed consent of the patient and the signed consent of the patient’s family members or relatives must be obtained.”The word“and”may reflect the hesitation about the subject’s right to self-determination in the law.Should only one party among the“patient,”“family members,”or“guardian”be informed,or all of them be informed? Where the subject has full capacity,is it possible to inform only the family members but not the subject?By what status do the family members receive the information? All these are real problems.Such legislative ambiguity may easily lead to difficulties in the application of laws.

Some scholars believed that the above-mentioned laws and regulations of China include“family members”as the object of the obligation to inform due to the consideration of the Chinese cultural tradition.28.Liu Yueshu,“Adaptation of Informed Consent Principle to the Chinese Context:A Transformation from the Perspective of Bioethics”,Studies in Ethics 1 (2013).In China,the family is traditionally regarded as a basic unit of society.When a family member falls ill,other family members always assume the responsibility of taking care of him/her and providing him/her with not only spiritual support but also practical medical care and economic support.They often have a good understanding of the patient’s needs and are therefore able to provide relevant information to the,medical staff.It is a characteristic of the Chinese medical tradition to pay attention to the opinions of family members.The roles of family members’ opinions in the informed consent process varies according to the different moral values and customs in different countries and the specific situation of the research subjects.However,it is not advisable to magnify the effect of family members’ opinions,allow them to participate in the process where the research subject with full capacity for civil conduct exercises his right of consent,or even listen only to the opinions of family members,regardless of the research subject’s consent.29.It is called“family patriarchy”in Taiwan Province of China,see Yang Xiuyi,An Investigation and Analysis of the American“Informed Consent”Principle,The Taiwan Law Review 121 (2005).In my eyes,there is no reason and no need for laws or administrative regulations to compulsorily stipulate family members as the object to be informed by the clinical investigators,because informed consent is a concentrated embodiment of the subject’s right to self-determination,30.Zhang Hongsong and Lan Liji,“A Study on Informed Consent in Human Experimentation”,Oriental Law 2(2013).and the research subject should be the one to be informed.Therefore,if the administrative authority requires the clinical investigators to pay attention to the opinions of family members in the model of informed consent in principle,it may be a safe practice that does not conflict with the legal principle of the right to informed consent.

Comparatively speaking,it seems more consistent with the protection of the right to self-determination in the right of informed consent to stipulate the object of the obligation to inform as the“subject or subject’s guardian,”“patient or his guardian,”31.There are essential differences in the legal concept between guardian and family members.The guardian’s consent right is stipulated based on the condition that the research subject is not capable of giving consent.not only because the subject will face great risks in human trials and need to consider carefully whether to participate in the trials or not,but also because the selection process will involve personal factors,such as ethical values and personal privacy.Such personal factors may make a difference in the results.Moreover,everyone knows him/herself the best and is the best person to make decisions for him/herself.

As John Stuart Mill wrote in his bookOn Liberty,“Over himself,over his own body and mind,the individual is sovereign.”32.John Stuart Mill,On Liberty,translated by Meng Fanli (Guilin:Guangxi Normal University Press,2011),10.In addition,if the right to informed consent is exercised on the subject’s family members' behalf,it may conflict with the protection of the research subject’s right to privacy.Especially,where the research subject is the target patient,the information grasped by the doctor,such as the patient’s medical history and degree of illness,may be considered private by the research subject which he/she may not want his/her family members to know.In this case,if the doctor informs the family of such information,it will violate the privacy right of the research subject.Furthermore,although family members usually act in the best interests of the subject,it cannot be denied that in real life,there are still some family members who go against the will of the subject,disregard the subject’s interests,or even damage the rights and interests of the subject in pursuit of some economic interests.To sum up,I think the subject with capacity for civil conduct should be the object of the obligation to inform,and the opinions of the subject’s family members should be valued which,however,should not replace the consent of the subject.Where the subject with no capacity for civil conduct participates in the trial,generally his guardian should be the one to be informed,but the situation varies depending on whether the trial has therapeutic benefits,etc..

B.Different degrees of detail in legislative provisions on the content of disclosure

The scope and content of disclosure are the most difficult part to define.What should the subject be informed about? What are the criteria for the researcher to fulfill the obligation to inform? We hope the research subject can be fully informed so that he/she can make a decision that is in his/her interests and worth,but at the same time,we worry that the research subject will be overwhelmed with too much information and frightened by uncertain risks,and hence negate the value of human trials.If experimenters conceal important data and information from the research subject in pursuit of their own interests,it will violate the right to informed consent of the research subject.Similarly,dumping all relevant information indiscriminately on the research subject will undoubtedly increase the research subject’s distress.

In routine medical treatment,doctors usually inform their patients of the medical procedures before diagnosis,name of the disease,state of illness,prognosis,and risks of refusing diagnosis;recommended therapeutic schedule,including the nature and purpose of the treatment,other possible alternative therapeutic schedules,and their advantages and disadvantages;recognized risks associated with the therapeutic schedule;expected results of treatment and potential conflicts of interest.33.Huang Dingquan,A New Study on Medical Law (Beijing:Law Press·China,2013),179.The substantial differences between human trials and routine medical treatment have been discussed above.The obligation of the clinical investigators to inform should be much stricter than that of the doctor in routine medical treatment,and should not be waived easily.So,what should the clinical investigators tell the subject,and what information is essential for the subject to make a decision?

International organizations and standards on human trials in various countries generally define the scope of disclosure by listing the specific scope.The second half of Article 1 of theNuremberg Codelists the contents of disclosure in detail.34.Article 1 of the Nuremberg Code stipulates that“… The subject should have sufficient knowledge and comprehension of the elements,such as the nature,duration,and purpose of the experiment;the method and means by which it is to be conducted;all inconveniences and hazards reasonably to be expected;and the effects upon his health or person which may possibly come from his participation in the experiment,so as to make a reasonable decision.”Article 26 of theDeclaration of Helsinkistates,“In medical research involving human subjects capable of giving informed consent,each potential subject must be adequately informed of the aims,methods,sources of funding,any possible conflicts of interest,institutional affiliations of the researcher,the anticipated benefits and potential risks of the study and the discomfort it may entail,and any other relevant aspects of the study.The subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal.Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.”

China’s legal norms on the content of disclosure are either detailed or brief because of their different types.For example,Article 1008 of theCivil Codebriefly summarizes the content of disclosure,that is,the clinical investigators shall disclose“the details including the purposes,methods,and the possible risks of the trial.”TheStandards for Quality Management of Drug Clinical Trials,theStandards for Quality Management of Medical Device Clinical Trials,and theMeasures for the Ethical Review of Biomedical Research Involving Humansset out in detail what informed consent should contain.TheStandards for Quality Management of Medical Device Clinical Trialsrevised in 2020 refers to the international practice and keeps in line with the basic requirements of ICH technical guidelines.The content of the informed consent should include 20 items,such as experimental conditions,purposes,probability of random grouping,experimental procedures,obligations of the subject,experimental content,risks or inconveniences of the subject,expected benefits,other optional drugs or therapies,damage compensation,expected costs,voluntary participation or refusal to participate and withdrawal at any time without reprisal,supervision and inspection,identity confidentiality,new information disclosure,the contact information of researchers and the ethics committee,termination of the trial,expected duration,expected number of subjects,and so on.35.Article 24 of the Standards for Quality Management of Drug Clinical Trials.The standards are rich in content and operable,and it is the most comprehensive regulation on informed consent in China.

It is also worth noting that the obligation of the experimenter to inform should be fulfilled not only before the beginning of the trials but also during the trials and within a reasonable time after the trials.As the obligation of the experimenter to inform is not fixed at a certain point in time,with the progress of human trials,there will be new obligations to inform.When the factors related to the subject’s rights and interests change in the trials,the basis on which the subject makes his decision of consent will change accordingly.Since such changes may be beyond the scope of the research subject’s original consent,the clinical investigators shall fulfill the obligation to inform the new changes.This is not only a requirement for protecting the right to informed consent of the subject but also an embodiment of mutual trust and good faith between the clinical investigators and the subject.Most clinical investigators hold that the process of informed consent is merely to sign an informed consent form or to meet the requirements of a legal obligation to inform simply.It is essential that the clinical investigators thoroughly discuss the possible risks of the trial project with the research subject,and it is necessary to give the research subject enough time to learn about the trials and consult and communicate with the clinical concerning any doubts,both of which help the subject make a reasonable decision based on careful consideration.

C.Consent of the subject:the exercise of the right to self-determination

As a manifestation of individualism,the right to self-determination enables individuals to decide freely how to deal with their personal or property rights and interests.In human trials,the right to self-determination is specifically embodied in the consent of the subject.A valid consent should include the following three elements:first,the subject is capable of giving consent;second,the subject has a full understanding of what the clinical investigators tell him/her;third,the research subject makes decisions voluntarily.1.Criteria for judging the capability of giving consent

The following criteria can be used to judge whether the research subject is capable of giving consent.The first is the criterion of capacity for the conduct,that is,take the capacity for civil conduct in the civil law as a criterion of judgment.The second is the criterion of capacity for responsibility,that is,take the capacity for criminal responsibility in the criminal law as a criterion of judgment.Scholars upholding the criterion of capacity for responsibility argue that the subject’s capacity for consent is similar to the capacity for responsibility in criminal law and different from the capacity for civil conduct in civil law and that it is not necessary to have the capacity for consent confined to adults.36.Weng Yurong,“On the Patient’s Right to Self-determination and the Doctor’s Obligation to Inform from a Legal Perspective”,Law Review 66,combined issue 1-3 (2000),8.The third criterion is mental capacity,that is,taking research subject’s mental capacity as a criterion of judgment.The fourth is a flexible criterion of mental capacity.Namely,when the risk factor of human trials is very high,a stringent criterion will be used to judge the subject’s capability of giving consent;when the human trials are less risky and more beneficial to the subject,a less stringent criterion will be used.

Article 23 (10) of theStandards for Quality Management of Drug Clinical Trialsin China stipulates:“Where a subject is a person without capacity for the conduct,the written informed consent shall be obtained from his guardian;where a subject is a person with limited capacity for civil conduct,the written informed consent shall be obtained from the subject and his guardian.”It can be seen that the criterion of capacity for civil conduct is used in China to judge the subject’s capability of giving consent.

2.The research subject’s comprehension of experimental information

The research subject’s full comprehension of experimental information provided by the clinical investigator’s is an essential condition for the effective exercising of the consent right.If the research subject fails to truly understand the experimental information,his/her consent will not be substantially valid.The research subject’s comprehension of experimental information is affected by two aspects of factors.First,subjectively,the difference in the comprehension ability of subjects will lead to different levels of comprehension of the information.Comprehension is a comprehensive ability,which is determined by the intelligence level,mental state,psychological maturity,and cultural level of the subject.Therefore,different subjects often have different abilities of comprehension.As a result,the clinical investigator must determine the best way to communicate the information according to the research subject’s comprehension ability.The way the information is presented may greatly affect the research subject’s comprehension.It is even as important as the information itself.For example,if the clinical investigators inform the research subject of the information in an ambiguous and confused manner,or do not give the research subject enough time to think about it,or enough opportunities to ask questions,it will hurt the research subject’s comprehension of the information.This also indicates that the research subject’s comprehension of information is limited by objective factors,such as whether the experimental information is provided adequately,whether it is distorted,whether it is provided appropriately,whether there is information concealment or intentional exaggeration,etc.

For researchers who have received professional training and possess professional knowledge,it is easy to understand the experimental behavior and information,but for research subjects who are usually less exposed to experimental knowledge,it is complicated.Therefore,to get substantially valid consent from the research subject,and fundamentally prevent the illegality of human trials,researchers should fully inform the research subject of their experimental purposes and methods,the physical condition or state of illness of the research subject,and possible risks and benefits of the experiment in an objective,rational and respectful manner,so as to ensure that the research subject can correctly understand the experimental information.In the process of informed consent,the clinical investigators should have a good interaction or communication with the research subject,give the research subject sufficient time for consideration and answer all his/her questions as far as possible.Meanwhile,the research subject must understand that the experimental purpose is to explore new medical knowledge,rather than merely a specific treatment for his disease.Even if the experiment can bring medical benefits to the research subject,the research subject should be informed of the risks of the experiment and the significance of agreeing to participate in the experiment.

3.Voluntary consent and dissent

The research subject should voluntarily decide whether to participate in the experiment or not based on a full understanding of the experimental information,and of his/her own free will,that is,without coercion,threat,or undue influence.Coercion is the deliberate use of violence or improper means to force others to make decisions that are contrary to their own will.A threat is an act of coercing others into agreeing to participate in human trials on the grounds of certain physical,mental,economic,or political damage.For example,threaten patients to participate in the trials they don’t intend to participate in because they will not receive proper treatment if they don’t do so.Undue influence refers to inducing subjects to participate in the trials with economic benefits,additional medical care services,etc.This kind of undue influence is often seen in recruitment announcements for human subjects and aims to lure financially disadvantaged patients or healthy people to participate in human trials,usually with the promise of free treatment,high economic compensation,the most advanced treatment,etc..Some of the subjects are either seriously ill patients who hope against hope that the new drug trial can save them,poor patients who cannot afford treatment,or professional drug test subjects who trade their health for financial rewards.Undue influence is often concealed,not so obvious,and easy to distinguish as coercion,threat,and other ways,but it will have a huge negative impact.It should be noted that decisions made by people under the influence of persuasive reasons,the needs of their families,and the requirements of legal obligations do not fall into the category of undue influence mentioned above.In today’s society,it is almost impossible to be completely free from the influence of others.Voluntary consent means to act according to one’s own free will,while it is not to be free from the influence of anyone else,but to be free from control,intimidation,interference,or deception.Article 1008 of theCivil Codestates that“written consent”must be obtained for clinical trials.“As the efficacy and safety of new drugs and medical devices in clinical trials need to be further confirmed,‘written consent’ is emphasized,rather than oral consent and process records”37.Liao Qixia,Lai Yonghong and Liu Junrong,“Issues of Informed Consent in Ethics Review of Clinical Research Projects”,Medicine &philosophy 19 (2021)..

Of course,a voluntary decision means a decision of consent or a decision of dissent.The refusal to participate in an experiment is also an embodiment of the subject’s exercise of the right to self-determination.Where the research subject thinks participating in the experiment is not in his/her own interests,he/she can decide to refuse to participate in it.Even during the experiment,the subject can choose to withdraw his/her consent and quit the experiment.The consent of the research subject is an embodiment of the victim’s promise in the human experimental relationship in civil law.“It is not to produce a certain legal effect,and it is not necessary to have legal effect.It involves the infringement of one’s own rights and interests.Thus,it is not a declaration of will,but a quasi-juristic act.”38.Wang Zejian,Tort Law 1——Basic Theory:General Torts (Beijing:China University of Political Science and Law Press,2003),303.The experiment begins with the consent of the research subject.If the research subject wants to withdraw his consent after deciding on consent,it shall be deemed as a withdrawal of consent.The withdrawal of consent should suspend the experiment that has started with the consent.No matter whether the experiment has been carried out or is being carried out,the subject can withdraw it,that is to say,the withdrawal of consent can occur at any time.Article 31 ofDeclaration of Helsinki2013,Article 5 of theInternational Ethical Guidelines for Biomedical Research Involving Human Subjects,CIOMS,39.In 1982,the Council for International Organization of Medical Science (CIOMS) and the World Health Organization (WHO) developed the Ethical Guidelines for Biomedical Trials jointly,which was renamed International Ethical Guidelines for Biomedical Research Involving Human Subjects when it was first revised in 1993,referred to as CIOMS International Ethical Guidelines.The Guidelines not only establishes the general rules of the right to informed consent,but also specify the norms for the informed consent of vulnerable subjects.Article 24 (13) of theStandards for Quality Management of Drug Clinical Trials,Article 25 of theStandards for Quality Management of Medical Device Clinical Trials,and Article 37 of theMeasures for the Ethical Review of Biomedical Research Involving Humansall stipulate that subjects have the right to withdraw from human trials at any stage without discrimination or retaliation,and their medical rights will not be affected.

IV.Conclusions

In recent years,as the number of human clinical trials has increased year by year,the number of disputes and lawsuits caused by the infringement of the right to informed consent of subjects also shows an increasing trend.How should we better protect the right to life and health of research subjects in human trials? What is the relationship between the right to informed consent and the right to life and health of the research subjects? How should we identify that the researcher fails to fully fulfill the obligation to inform? If the experimenter failed to fulfill its obligation to inform,and violates the research subject’s right to be informed,which caused the subject to make a decision completely against his/her will,and results in damage to his/her life and health,should the research subject claim for damages against the research institution because his life and health have been violated,or should he file a lawsuit because his right to informed consent has not been effectively protected? In the circles of legal theory and judicial practice,the problem of legal liability caused by the violation of the right to informed consent of research subjects in human trials has drawn increased attention and discussion.Especially,such questions as who and what should be informed when researchers fulfill the obligation to inform,and what criteria are used to determine whether researchers have fully and completely fulfilled the obligation to inform,have become the topics discussed and the focus of research.It is believed that the legal protection of the right to informed consent of research subjects in China will continue to be deepened and improved in practice in the future.

Meanwhile,it should also be noted that protecting the right to informed consent of research subjects and safeguarding their right to self-determination depends on not only the construction of legal theories and systems but also the experimenter’s sincere recognition of and respect for the research subject’s right to self-determination.This requires the enhancement of the ethical and legal awareness of biomedical researchers and experimenters,as well as the improvement of the overall cultural atmosphere and the formation of a social consensus to respect human rights and self-determination.